Shiga Progression of Diabetes, Nephropathy and Retinopathy (SHIP-DINER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Shiga University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Kanazawa Medical University
Nagahama Red Cross Hospital
Nagahama city Hospital
Kohka Public Hospital
Second Okamoto General Hospital
Omihachiman COmmunity Medical Center
Yasu Hospital
Toyosato Hospital
Ako City Hospital
Horide Clinic
Kawabata Clinic
Seta Clinic
Shiga Clinic
Osaka University
NTT West Osaka Hospital
Hyogo prefectural Amagasaki Hospital
Tomita Clinic
Sawada Clinic
Social Insurance Shiga Hospital
Information provided by:
Shiga University
ClinicalTrials.gov Identifier:
NCT00846716
First received: December 11, 2008
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese type 2 diabetic patients.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Pioglitazone add on to SU or biguanide
Drug: SU or Biguanide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on

Resource links provided by NLM:


Further study details as provided by Shiga University:

Primary Outcome Measures:
  • Onset and progression of diabetic nephropathy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression of diabetes mellitus change from the baseline in HbA1c change from the baseline in albumine/creatinine ratio change from the baseline in cystatin C onset and progression of diabetic retinopathy safety assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone add on to SU or biguanide Drug: Pioglitazone add on to SU or biguanide
As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.
Active Comparator: SU or Biguanide Drug: SU or Biguanide
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.

Detailed Description:

2. Outcome measures:

  1. Primary endpoint Onset or progression of diabetic nephropathy
  2. Secondary endpoints (1)Progression of diabetes mellitus (2)Change in HbA1c (3)Change in albumin-creatinine ratio (4)Change in GFR (5)CHange in cystatin C
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Less than 8.0% in HbA1c
  • Less than 300 mg/g Cr of urinary albumine level
  • Concomitant therapy with SU and/or Biguanide
  • Untreated hypertension and hypertension treated with ARB or ACEI

Exclusion Criteria:

  • History of heart failure and concomitant heart failure
  • History of administration of TZD agent
  • Severe hepatic dysfunction with more than 3 times higher than upper limit of normal range of GOT, GPT or rGPT
  • Severe renal dysfunction with more than 2.5 of Cr
  • History of AE with TZD agent
  • Insulin treatment
  • Concomitant urinary track infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846716

Contacts
Contact: Hiroshi Maegawa, PhD +81-77-548-2222 maegawa@belle.shiga-med.ac.jp
Contact: Takashi Uzu, PhD +81-77-548-2222 tuzu@belle.shiga-med.ac.jp

Locations
Japan
Shiga University of Medical Science Recruiting
Otsu, Shiga, Japan, 520-2192
Contact: Hiroshi Maegawa, PhD    +81-77-548-2222    maegawa@belle.shiga-med.ac.jp   
Contact: Takashi Uzu, PhD    +81-77-548-2222    tuzu@belle.shiga-med.ac.jp   
Principal Investigator: Yoshihiko Nishio, PhD         
Principal Investigator: Takashi Uzu, PhD         
Principal Investigator: Masato Ohji, PhD         
Sub-Investigator: Osamu Sawada, PhD         
Principal Investigator: Daisuke Koya, PhD         
Sponsors and Collaborators
Shiga University
Kanazawa Medical University
Nagahama Red Cross Hospital
Nagahama city Hospital
Kohka Public Hospital
Second Okamoto General Hospital
Omihachiman COmmunity Medical Center
Yasu Hospital
Toyosato Hospital
Ako City Hospital
Horide Clinic
Kawabata Clinic
Seta Clinic
Shiga Clinic
Osaka University
NTT West Osaka Hospital
Hyogo prefectural Amagasaki Hospital
Tomita Clinic
Sawada Clinic
Social Insurance Shiga Hospital
Investigators
Study Chair: Atsunori Kashiwagi, PhD. Tsukiwa-machi, Seta, Otsu, Shiga, Japan
  More Information

No publications provided

Responsible Party: Atsunori Kashiwagi, Shiga University of Medical Science
ClinicalTrials.gov Identifier: NCT00846716     History of Changes
Other Study ID Numbers: 2008.9.18 ver2-4
Study First Received: December 11, 2008
Last Updated: February 18, 2009
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Shiga University:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Diabetic Retinopathy
pioglitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014